Clinical Trial: An Open-label Study to Assess the Safety and Effectiveness of AA4500 in Combination With the ErecAid® Esteem® Manual Vacuum Therapy System in Treating Men With Peyronie's Disease

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Phase 3b, Open-label Pilot Study to Evaluate the Safety and Effectiveness of up to Four Treatment Cycles of AA4500 in Combination With the ErecAid® Esteem® Manual Vacuum Therapy System in

Brief Summary:

Enrollment will include approximately 30 AA4500 naïve subjects. Subjects will be divided by degree of penile curvature and then randomized in a 1:1 ratio to one of the following treatment groups:

  • AA4500 with investigator modeling
  • AA4500 without investigator modeling

Each subject will receive 2 injections of AA4500, separated by approximately 24 hours to 72 hours, repeated after 42 days (± 5 days) for up to 4 treatment cycles.

Approximately 14 days after the second injection of AA4500, each subject will visit the study site and the investigator will assess the subject and instruct the subject on appropriate use of the ErecAid® Esteem® Manual Vacuum Therapy System.


Detailed Summary:
Sponsor: Endo Pharmaceuticals

Current Primary Outcome: Percent in improvement from baseline in penile curvature [ Time Frame: 36 Weeks ]

measurement of erect penis at day 42 (cycle 2), day 84 (cycle 3), day 126 (cycle 4), day 168 (follow up visit 1) and day 252 (follow up visit 2)


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Change in Peyronies disease bother [ Time Frame: 36 Weeks ]
    Questionnaire at Day 168 (follow up 1) and day 252 (follow up 2)
  • Change in Peyronies disease physical symptoms [ Time Frame: Week 36 ]
    measurement of erect penis at day 42 (cycle 2), day 84 (cycle 3), day 126 (cycle 4), day 168 (follow up visit 1) and day 252 (follow up visit 2)
  • Change in Peyronies disease psychological symptoms [ Time Frame: 36 Weeks ]
    Questionnaire at Day 168 (follow up 1) and day 252 (follow up 2)
  • Change in penile plaque consistency [ Time Frame: 36 Weeks ]
    Flaccid penile exam at day 42 (cycle 2), day 84 (cycle 3), day 126 (cycle 4), day 168 (follow up visit 1) and day 252 (follow up visit 2)
  • Change in penile length [ Time Frame: 36 Weeks ]
    Flaccid penile exam at day 42 (cycle 2), day 84 (cycle 3), day 126 (cycle 4), day 168 (follow up visit 1) and day 252 (follow up visit 2)3), day 126 (cycle 4), day 168 (follow up visit 1) and day 252 (follow up visit 2)
  • Change in Peyronies disease penile pain [ Time Frame: 36 Weeks ]
    examination for pain done on day 42 (cycle 2), day 84 (cycle 3), day 126 (cycle 4), day 168 (follow up visit 1) and day 252 (follow up visit 2)
  • A responder analysis based on subject global assessment [ Time Frame: 36 Weeks ]
    Questionnaire at Day 168 (follow up 1) and day 252 (follow up 2)


Original Secondary Outcome: Same as current

Information By: Endo Pharmaceuticals

Dates:
Date Received: October 7, 2014
Date Started: October 2014
Date Completion:
Last Updated: June 17, 2016
Last Verified: October 2015